Method and apparatus for restraining a patient&#39;s leg during leg surgical and interventional procedures

ABSTRACT

An improved method and apparatus for restraining a patient&#39;s leg during knee surgery or similar procedure features and improved restraining member that is attachable to an operating room table. The restraining member has a lower concave portion that engages the upper portion and sides of the patient&#39;s leg. The restraining member has an upper convex portion that is reinforced with a plurality of ridges. The concave portion can be fitted with an inflatable bladder. The concave portion in other embodiments is fitted with a belt arrangement that enables different degrees of constriction to be imparted to the leg.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 13/570,624,filed Aug. 9, 2012 (issuing as U.S. Pat. No. 8,689,793 on Apr. 8, 2014),which is a continuation in part of U.S. patent application Ser. No.11/566,485, filed Dec. 4, 2006, which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/845,833, filed Sep. 19, 2006,U.S. Provisional Patent Application Ser. No. 60/816,842, filed Jun. 27,2006, U.S. Provisional Patent Application Ser. No. 60/794,164, filedApr. 24, 2006, and U.S. Provisional Patent Application Ser. No.60/761,402, filed Jan. 23, 2006, each of which is hereby incorporatedherein by reference and priority of which is claimed.

Priority of U.S. Provisional Patent Application Ser. No. 60/845,833,filed Sep. 19, 2006, incorporated herein by reference, is herebyclaimed.

Priority of U.S. Provisional Patent Application Ser. No. 60/794,164,filed Apr. 24, 2006, incorporated herein by reference, is herebyclaimed.

Priority of U.S. Provisional Patent Application Ser. No. 60/816,842,filed Jun. 27, 2006, incorporated herein by reference, is herebyclaimed.

Priority of U.S. Provisional Patent Application Ser. No. 60/761,402,filed Jan. 23, 2006, incorporated herein by reference, is herebyclaimed.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO A “MICROFICHE APPENDIX”

Not applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices for holding or securing the legof a patient during knee arthroscopy surgery and any other medicalprocedures that require immobilizing of a patient's leg. Moreparticularly, the present invention relates to a leg restrainingapparatus that is connectable to an operating room table and that holdsthe patient's leg above the knee during knee surgery or like medicalprocedures. Even more particularly, the present invention relates to animproved method and apparatus for restraining the leg of a patient abovethe knee wherein a specially configured restraining member is equippedin one embodiment with an inflatable bladder that interfaces between therestraining member and the patient's leg and in other embodiments,cradles the leg both above and below and in other embodiments, providesan interlocking ratcheting mechanism that enables a surgeon toselectively tighten the device around the patient's leg.

2. General Background of the Invention

During numerous medical procedures, the leg of a patient must berestrained. For example, a patient's leg must be restrained during kneesurgery.

There is a prior U.S. Pat. No. 4,766,892 issued to Gary Krietman thatdiscloses a leg restraint device adapted for orthopedic examinations andoperating procedures that provides a firm support for a portion of apatient's limb while the limb or joint is manipulated or stressed. Therestraint includes a rigid frame which defines a partially enclosed areawithin which the patient's limb is inserted. The enclosed area of theframe accommodates a blood pressure type air bag cuff which is securedto the frame by a fastener. Restraintive force is applied to the limband monitored by pressurizing the air bag to a controlled level. In oneembodiment, the partially enclosed area is shaped as an inverted “U” andwith the operating table providing the bottom closure. In a furtherembodiment, the frame includes a horizontal weigh which extends alongthe operating table and terminates at an upward laterally curved jaw. Anadjustable medially curved jaw is positioned along the weigh. After theadjustable jaw has been positioned, the air bag is pressurized torestrain the limb.

The present invention is an improvement of the device shown in theKrietman U.S. Pat. No. 4,766,892.

BRIEF SUMMARY OF THE INVENTION

The method and apparatus of the present invention incorporates the useof a polycarbonate materials combined with a air bladder to fixate theleg for the purposes of a medical procedure, such as knee arthroscopyand other procedures that include but are not limited to EP studies,vascular intervention via catheters, where the leg is required to remainimmobile to facilitate the medical procedure.

The apparatus of the present invention is unique in its concept andstructural design, incorporating proprietary structural ridges andsupport biases, to provide the stiffness and strength characteristics towithstand a minimum of 50 lbs lateral force when flexing valgus andvarus angle pressure on the knee joint for arthroscopic knee surgeryexposure.

The present invention utilizes an intricate design of Celstran ridges,supports, cross members, and diagonal supports.

The apparatus of the present invention is designed to be both a“disposable leg restraint”, and/or a re-useable device in those marketsthat are not suited for a disposable device. The device weighs between 1and 1.5 lbs, and is made of about 60% glass polycarbonate material(s).

The present invention is light weight, can be disposable, and negatesany cross contamination potential for infection and affords directaccess to all points of the knee joint. The apparatus of the presentinvention provides ease of use and set-up, cost effectiveness byavoiding re-sterilization, cleaning, and administrative costs such asrecord keeping and liability costs.

The apparatus of the present invention does not act as a tourniquet, andallows for continuation of procedure during long cases requiring releaseof tourniquet, permits limited blood flow-safety factor. The apparatusof the present invention provides enhanced patient comfort and safetyvia air bladder that insures equal distribution of stress forces. Theapparatus of the present invention can be sterile draped and is readilyremovable during surgical procedure (w/o breaking sterility) extendingoperative field.

The apparatus of the present invention can be manufactured as a singlemolded piece and/or a two section piece incorporating a metal stem(SS/titanium/etc) attached to a polycarbonate arc that supports the airbladder cushion system for immobilizing the leg.

The materials can comprise 60% long strand glass and polycarbonateplastics (e.g. Celstran PA66-GF60-02-BK) and can be produced in avariety of colors (black, natural, yellow, red, blue).

An optional bottom attachment can be used to connect the proximalportion of the arc and the distal end of the arc, in the event that itmight be required to provide addition stiffness to the overall brace.The attachment would be passive, merely clipping into place, andsupporting additional lateral force, should it be needed.

The present invention incorporates a unique approach to fixating the legvia two methods. In a first method, a base (e.g. Celestran) withinterlocking teeth on both sides of the base engage two semi circularpieces that complete the encirclement of the leg, around a circular foampadding (adjusts for size). The operator merely tightens the encirclingpieces to the desired tension/fixation position by pressing inward andengaging the next set of teeth on the ends of the two encircling pieces.

The tension of encirclement increases the engagement on the teeth sinceall the pressure is outward keeping the teeth well engaged into oneanother. To release, one merely pulls upward on the piece with thehandle, and the system of encirclement releases pressure totally,allowing for the removal of the device after the procedure. The attachedCAD drawings clearly depict the construction and design of the device,alluding to the unique structural supports required to withstand thelateral pressures of knee surgery requirements.

In a second procedure and embodiment, a base that is somewhat larger andmore encompassing than “a” provides a more stabilizing structure toattach a ridged belt that serves to encircle the leg, pass through ageared mechanism that has a locking pin to immobilize the gear and fixthe belt at the desired point of tension/fixation.

The tension on the belt is achieved by merely pulling downward/outwardon the belt as it passes thru the gear and out of the base housing, andat the desired tension is fixed by engaging the locking pin to the gear.This locks the belt in place, and it can not be released withoutdisengaging the locking pin.

The ridged belt can be padded with a foam pad between the belt and thepatients leg. Either of these devices can be manufactured as“disposable” devices, and re-useable devices for those markets that donot lend themselves to disposable products. The foam pads would be adisposable item helping to eliminate the potential for crosscontamination and/or infection on both embodiments. These devices can bemanufactured as a single base portion with the above describedattachments/components, and are unique in design and concept forfixating a leg for the purposes of providing leg stability for medicalprocedures such as arthroscopic knee surgery and any other medicalprocedures that require the use of keeping the leg immobile (such as EPstudies, vascular catheter intervention-angioplasty and/or stentplacement). The first embodiment involves the use of an air bladder anddoes not totally encircle the leg tension. The second embodiment does infact encircle the leg and does perform a limited tourniquet effect,while not employing the air bladder. Both embodiments are for practicalpurposes, aside of design and mechanical function, provide the samefeatures, benefits and advantages. Both can be disposable in nature orre-useable as well. The re-useable model in both embodiments wouldincorporate a disposable feature. The “air bladder” could be adisposable item. The foam pad would be a disposable item. Whendesignated as a single use device, the entire device would be disposedof after each use.

The present invention includes a limb restraining apparatus for use incombination with a table upon which a patient is resting, comprising: arestraining member removably attached to the table, the restrainingmember being an integrally molded plastic member having a curvedunderside concave portion that is positioned to cradle the patient's legfrom a position above the patient's leg; the restraining memberpreventing substantial movement of the patient's limb while allowingmovement and manipulation of a distal limb section; a flexible supportattached to the concave portion of the restraining member; and the uppersurface of the restraining member being a convex surface that isreinforced with a plurality of webs that intersect to form acute angles.

Preferably, flexible support is an inflatable cuff.

Preferably, the present invention further comprises a cradle thatremovably fits the restraining member, the cradle having an upwardlyfacing concavity that cradles the patient's leg from below.

Optionally, the restraining member is of a polycarbonate material.

Optionally, the restraining member is of a glass polycarbonate blend.

Optionally, the restraining member is of in excess of 50% long strandglass and polycarbonate plastic material.

Preferably, the cuff includes an inflation stem, the restraining memberincluding an aperture, the stem extending through the aperture tofacilitate inflation.

The present invention includes a method of accessing areas of a limbjoint for insertion and manipulation of arthroscopic instruments duringanthroscopic examination or surgery, the method comprising the steps of:confining a first zone of a limb with a restraining member that has adownwardly facing concavity that covers the top and at least part of thesides of the limb, said restraining member including on the inside anair bag cuff, the first zone being positioned between the patient's bodyand the joint, said restraining member including on the outside aplurality of structural ridges that form multiple acute angles;immobilizing the air bag cuff; inflating the cuff to a minimumpredetermined pressure to restrain the first zone from movement;monitoring and maintaining the inflating pressure while stressing thelimb joint, the stressing of the joint being attained by applying forcesto a second zone of the limb, the second zone being spaced from thejoint in a direction away from the patient's body.

Preferably, the limb is a leg, the joint comprising a knee joint, thefirst zone comprising a portion of a thigh, the step of immobilizing theair bag cuff comprising immobilizing the cuff adjacent the top andopposite sides of the thigh.

Preferably, the confining step includes positioning the cuff only aroundthe top and sides of the thigh, the underside of the thigh being free ofcontact with the inflated cuff.

Preferably, the joint is stressed by applying rotational stress to thesecond zone relative to the first zone.

Preferably, the step of immobilizing the cuff comprises fixing the cuffwith respect to a rigid frame, the frame being operatively positioned tooverlie the air bag cuff, the fixing step comprising peripherallysecuring the cuff to the frame, the frame being spaced from the firstzone.

The present invention includes a method of restraining a portion of alimb of a patent resting upon a surgical table for orthopedicexamination and operating procedures upon a joint of the limb, themethod comprising the steps of: providing a restraining member having arigid support that surrounds the top and sides of the limb to berestrained, said restraining member having an upper convex surfacereinforced with a plurality of intersecting ridges and a lower concavesurface that engages a patient's leg, and an inflatable cuff on thelower curved surface; registering the restraining member with a firstzone of the limb, the first zone being spaced from the joint in adirection towards the patient's torso by adjustably anchoring the rigidsupport means to the table at a selected position along the length ofthe table, the support means being out of direct contact with the limb;peripherally confining the first zone of the limb except for anunderside portion of the first zone resting upon the surgical table withthe inflatable cuff; applying restraintive force to the first zone byinflating the cuff to a pressure while immobilizing portions of the cuffspaced from the first zone of the limb with the rigid support means;monitoring and maintaining the inflated pressure of the cuff for theduration of the operating procedure; and separating portions of thejoint to permit the insertion and manipulation of arthroscopicinstruments by applying controlled forces to a second zone of the limb,the second zone being spaced from the joint in a direction away from thefirst zone.

Preferably, the cuff includes an outer periphery, the step of inflatingand immobilizing the cuff includes the step of anchoring the cuff to therestraining member.

Preferably, the restraining member includes a plastic frame having adepending leg, the step of anchoring including anchoring the restrainingmember to the table by inserting the flange into a slot which providedon the table.

The present invention includes a method of stabilizing and renderingimmobile the thigh area of a patient for cardiovascular interventionprocedures involving the placement of catheters and/or instruments inthe patient's cardiovascular system via the femoral arterial vessel,whereby catheter placement and maintenance of position is vital tosuccessful angioplasty intervention and/or placement of arterial stents.

The present invention includes a limb restraining apparatus for use incombination with a table upon which a patient is resting, comprising: arestraining member removably attached to the table, the restrainingmember being an integrally molded plastic member having a curvedunderside concave portion that is positioned to cradle the patient's legfrom a position above the patient's leg; the restraining memberpreventing substantial movement of the patient's limb while allowingmovement and manipulation of a distal limb section; a flexible beltattached to the restraining member, the belt extending about 360 degreesfor encircling and holding a patient's leg; and interlocking portions ofthe belt enabling the belt to adjust to legs of differing sizes.

Preferably, the belt has multiple sections.

Preferably, the belt has interlocking toothed portions.

Preferably, the belt has a handle at one end portion for enablingtension to be applied to the belt.

Preferably, the belt has belt teeth on a surface of the belt and furthercomprising a toothed wheel on the restraining member that engages thebelt teeth.

Preferably, the toothed wheel can be rotated to tighten or loosen thebelt about a patient's leg.

Preferably, the belt has teeth on a belt outer surface, the belt havingan inner surface that engages the patient's leg.

Preferably, there is a locking device that locks movement of the beltand wheel in a selected position.

Preferably, the locking device comprises aperatures on the wheel and alocking pin that can interlock with a selected one of the aperatures.

The present invention includes a tourniquet in order to lower theposition of the tourniquet from the high thigh to proximal to the kneejoint, thus reducing potential tissue and vascular damage caused by thetourniquet on the upper thigh area.

The present invention can be used for procedures including ACL repairs,arthroscopy meniscus repair, and vascular intervention.

The present invention includes a single device with no moving partsand/or attachments. The present invention does not require added bottomsupport. The present invention can be used on various patients,including small school soccer players, older athletes, adults andelderly (both slim and obese).

In the present invention, a surgeon can use the device for quick caserepairs. Using the device of the present invention, a surgeon canperform a surgery in a seated position. The present invention saves timeand costs. Patients benefit from the comfort and stability of thepresent invention. There is less operative time and lower costsassociated with use of the present invention. One other advantage isthat the apparatus of the present invention standardizes thearthroscopic procedure approach for every patient. The device is easy toset up and avoids MCL tears during surgery that would occur usinganother apparatus.

The present invention includes a method of accessing areas of a legjoint of a patient who is supported upon an operating room table, forinsertion and manipulation of arthroscopic instruments during surgicalarthroscopic examination of the patient's leg joint. The method providesa restraining member that removably attaches to the operating roomtable, the restraining member having a connecting portion that includesa flange and that attaches to the table, a curved section having a freeend, and a thickened transition section that joins the connecting flangeto the curved section, the transition section having a first taperedportion connecting to the flange and a second tapered portion connectedto the curved section, said first and second tapered sections joinedtogether. A first zone of the patient's leg can be confined with therestraining member, wherein the restraining member covers the top andpart of the sides of the patient's leg, but does not engage theunderside of the patient's leg that rests upon the operating room table.The curved section can extend over but does not encircle the patient'sleg.

In one embodiment, the joint can comprise the patient's knee joint, thefirst zone can comprise a portion of the patient's thigh, and furthercomprises the step of selectively immobilizing the leg with aninflatable cuff adjacent the top and sides of the patient's thigh byinflation of said cuff.

In one embodiment, the cuff can be placed only around the top and sidesof the patient's thigh, the underside of the thigh being free of contactwith the inflatable cuff.

In one embodiment, the patient's leg joint can be stressed by applyingrotational stress to a second zone of the patient's leg relative to thesaid first zone.

In one embodiment, the inflatable cuff can be not connected to thepatient's thigh at a position spaced proximally of the restrainingmember.

The present invention includes a method of restraining a portion of aleg of a patient resting upon a surgical table for orthopedicexamination upon a knee joint of the patient's leg. The method canprovide a restraining member having a rigid curved support thatsurrounds the top and sides of the leg to be restrained, saidrestraining member having a lower concave curved surface that engagesthe patient's leg, and an inflatable cuff on the lower concave curvedsurface. The restraining member can be registered with a first zone ofthe patient's leg above the knee, the first zone being spaced from theknee joint in a direction towards the patient's torso by adjustablyanchoring the rigid support member to the table at a selected positionalong the length of the table. The first zone of the leg can beperipherally confined with the curved support. The underside of thepatient's leg can be rested upon the surgical table. Portions of thejoint can be separated to permit the insertion and manipulation ofarthroscopic instruments by applying controlled forces to a second zoneof the leg below the knee, the second zone being spaced from the kneejoint in a direction away from the first zone. The restraining memberdoes not encircle the patient's leg in any of the steps.

In one embodiment, the inflatable cuff can be connected to the curvedsupport and further comprise selectively inflating the cuff.

In one embodiment, the restraining member can include a plastic framehaving a flange and anchoring the flange to the table by inserting theflange into a slot on the table.

The present invention includes a leg restraining apparatus for use inknee surgery wherein a patient is resting on an operating room table.The invention can comprise a restraining member removably attached tothe said table, the restraining member being an integrally molded,generally semicircular plastic member having a curved underside concaveportion that can be sized and shaped to conform the patient's leg from aposition above the patient's leg. The restraining member can preventsubstantial movement of the patient's leg while allowing movement andmanipulation of the patient's distal leg section. An inflatable cuff canbe attached to the restraining member, the cuff extending only a partialdistance around the patient's leg including engaging the upper surfaceof the patient's leg but not the underside of the patient's leg.

The present invention includes a leg restraining apparatus for use inknee surgery and in combination with a surgical table upon which apatient is resting. The invention includes a restraining member that canbe removably attached to the table, the restraining member being anintegrally molded plastic member having a curved section with anunderside concave surface that is positioned to cradle part of thepatient's leg from a position above the patient's leg. The restrainingmember can prevent substantial movement of the patient's leg whileallowing movement and manipulation of that patient's distal leg sectionbelow the patient's knee. The restraining member can have a connectorthat enables connection to the table. The restraining member can have athickened section in between the connector and the curved section, thethickened section including first and second tapered sections that arejoined at a location of maximum cross sectional area of the thickenedsection.

In one embodiment, the restraining member can have first and second endportions, the first end portion can have a connector that enablesconnection to the surgical table, the second end portion can be a freeend portion opposite the connector. The underside concave surface of thecurved section can form an arch in between the connector and the freeend portion of the restraining member.

In one embodiment, the present invention can further comprise aninflatable cuff attached to said curved section.

In one embodiment, the inflatable cuff does not encircle the patient'sleg.

In one embodiment, the present invention can further comprise a cradlethat can be removably connectable to the restraining member, the cradlehaving an upwardly facing concavity that cradles the patient's leg frombelow.

In one embodiment, the restraining member can be of a polycarbonatematerial.

In one embodiment, the restraining member can be of a glasspolycarbonate blend.

In one embodiment, the restraining member can be of in excess of 50%long strand glass and polycarbonate plastic material.

In one embodiment, the cuff can include an aperture, the connectorextending through the aperture to facilitate inflation.

In one embodiment, the restraining member extends about half way aroundthe patient's leg.

In one embodiment, the first tapered section can be attached to theconnector and a second tapered section can be attached to the curvedsection, wherein the first tapered section has a smallest crosssectional area next to the connector.

In one embodiment, the first tapered section can be attached to theconnector and the second tapered section can be attached to the curvedsection, wherein the second tapered section has a smallest crosssectional area next to the curved section.

In one embodiment, the first tapered section can have two surfaces thatform an acute angle.

In one embodiment, the second tapered section can have two surfaces thatform an acute angle.

In one embodiment, an obtuse angle can be formed by one surface of thefirst tapered section and one surface of the second tapered section.

The present invention includes a leg restraining apparatus for use inknee surgery on a leg of a patient, the leg having an upper portion andan underside and a knee, and in combination with a surgical table uponwhich the patient is resting, comprising:

a) a restraining member removably attached to the surgical table, therestraining member being an integrally molded plastic member having acurved section with an upper convex surface and an underside concavesurface that is positioned to engage the upper portion of the patient'sleg from a position above the patient's leg but does not engage theunderside of the patient's leg;

b) the restraining member adapted to prevent substantial movement of thepatient's leg above the patient's knee while allowing movement andmanipulation of a distal leg section below the patient's knee;

c) the restraining member having first and second end portions, thefirst end portion of the restraining member having a connector thatenables connection to the surgical table, the second end portion of therestraining member being a free end portion opposite the connector;

d) the restraining member having a thickened section that forms aninterface in between the connector and the curved section, the thickenedsection including first and second tapered sections that are joined at alocation of maximum cross sectional area of the thickened section;

e) wherein said underside concave surface forms an arch in between theconnector and the free end portion;

f) the thickened section including a plurality of surfaces including afirst surface that is in direct communication with the said undersideconcave surface, a second surface that is in communication with saidupper convex surface and which extends from the upper convex surface tothe connector, and a third surface that extends between said connectorand said first surface;

g) wherein said first and second surfaces form an acute angle; and

h) wherein said first and third surfaces form an obtuse angle.

The present invention includes a leg restraining apparatus for use inknee surgery on a leg of a patient, the leg having an upper portion andan underside and a knee and a distal leg section below the knee, and incombination with a surgical table upon which the patient is resting,comprising:

a) a restraining member removably attached to the surgical table, therestraining member being an integrally molded plastic member having acurved section with first and second end portions, an upper convexsurface, and an underside concave surface that is positioned to engagethe upper portion of the patient's leg from a position above thepatient's leg but does not engage the underside of the patient's leg;

b) the restraining member adapted to prevent substantial movement of thepatient's leg while allowing movement and manipulation of the patient'sdistal leg section below the patient's knee;

c) the restraining member having a connector that enables connection tothe surgical table;

d) the restraining member having a thickened section that forms aninterface between the connector and the first end portion of the curvedsection, the thickened section including first and second taperedsections that are joined at a location of maximum cross sectional areaof the thickened section;

e) the thickened section including a plurality of surfaces including afirst surface that is in direct communication with said undersideconcave surface, a second surface that is in communication with the saidupper convex surface at said first end portion of the curved section,and a third surface that extends between said connector and said firstsurface, said first and third surfaces forming an obtuse angle;

f) wherein the curved section terminates at said second end portionopposite the connector; and

g) wherein said underside concave surface forms an arch in between theconnector and the second end portion.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

For a further understanding of the nature, objects, and advantages ofthe present invention, reference should be had to the following detaileddescription, read in conjunction with the following drawings, whereinlike reference numerals denote like elements and wherein:

FIG. 1 is a fragmentary perspective view of a preferred embodiment ofthe apparatus of the present invention;

FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1;

FIG. 3 is a sectional view taken along lines 3-3 of FIG. 1;

FIG. 4 is a top view taken along lines 4-4 of FIG. 1;

FIG. 5 is a partial perspective view of a preferred embodiment of theapparatus of the present invention;

FIG. 6 is a partial perspective view of a preferred embodiment of theapparatus of the present invention;

FIG. 7 is a partial perspective view of a preferred embodiment of theapparatus of the present invention;

FIG. 8 is a perspective view of a preferred embodiment of the apparatusof the present invention;

FIG. 9 is a fragmentary perspective exploded view of a preferredembodiment of the apparatus of the present invention;

FIG. 10 is a close-up perspective view of a preferred embodiment of theapparatus of the present invention;

FIG. 11 is a fragmentary perspective view of a preferred embodiment ofthe apparatus of the present invention illustrating a differentconstruction for the restraining member;

FIG. 12 is a fragmentary perspective view of a preferred embodiment ofthe apparatus of the present invention illustrating a differentconstruction for the restraining member;

FIG. 13 is a fragmentary perspective view of a preferred embodiment ofthe apparatus of the present invention illustrating a differentconstruction for the restraining member;

FIG. 14 is a perspective view of an alternate embodiment of theapparatus of the present invention;

FIG. 15 is a perspective view of an alternate embodiment of theapparatus of the present invention;

FIG. 16 is a sectional elevation view of the second embodiment of theapparatus of the present invention;

FIG. 17 is a fragmentary sectional view of the second embodiment of theapparatus of the present invention;

FIG. 18 is an exploded perspective view of the second embodiment of theapparatus of the present invention;

FIG. 19 is a perspective view of a third embodiment of the apparatus ofthe present invention;

FIG. 20 is a perspective view of a third embodiment of the apparatus ofthe present invention; and

FIG. 21 is a sectional view taken along lines 21-21 of FIG. 19.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-10 show a preferred embodiment of the apparatus of the presentinvention designated generally by the numeral 10 in FIG. 8.

Leg restraint apparatus 10 is shown in use in FIG. 8 with a standardoperating room table 11 having an upper surface 12 that is receptive ofa patient 13. During certain types of orthopedic examination proceduresor surgeries, it is necessary to restrain or immobilize a patient's leg14. A locking mechanism 15 is used in combination with table 11 to holdthe leg 14 of a patient 13. The locking mechanism 15 includes a body 16that is mounted to the table 11. The body 16 provides a vertical slot 17intersected laterally with an internally threaded opening 18 that isreceptive of threaded set screw 19. In this fashion, restraining member20 or 20A or 20B can be inserted into slot 17 and then clamped andrigidly held to body 16 when set screw 19 is tightened relative to body16. Operating room tables 11 typically have instrumentation holders forvaried apparatus that slide along table rails for positioning, thenclamped down in accordance with the patient's height/size.

The restraining member 20, 20A, 20B can include a vertical or mountingflange 22 to which is integrally attached a thickened section 23 and acurved section 21. The restraining member 20, 20A, 20B is of adisposable plastic material, such as of injection molded plastic.

Curved section 21 provides an upper surface 24 that is reinforced with aplurality of longitudinal webs 25 and a plurality of diagonallypositioned webs 26. Lower surface 27 of curved section 21 is preferablysmooth, as shown in FIGS. 1 and 2. As seen in FIG. 2, flange 22 hasinner surface 22 a and outer surface 22 b. Thickened section 23 hassurfaces 23 a, 23 b, 23 c. Surfaces 22 a, 23 b form a first obtuseangle. Surfaces 22 b, 23 c form a second obtuse angle that is largerthan the first obtuse angle.

The first obtuse angle created by surfaces 22 a and 23 b can bepreferably 121°-125°, and most preferably 123°. The second obtuse anglecreated by surfaces 22 b and 23 c can be preferably 141°-145°, and mostpreferably 143°. This is preferably the angle range at which thethickened section 23 can be molded and therefore maintain the requiredrigidity and strength of the brace arc. A different angle could be usedbased on the different size of the overall arc/brace required, forexample, to accommodate smaller or larger leg mass based on the size ofa person. Adjusting the angle to a greater or a smaller angle wouldresult in a reduced or increased arc facilitating the overall size ofthe brace and its use with different leg sizes. This variation of angleranges would allow for extreme sizes and possibly rigidity and strengthissues when made with hybrid materials.

The angles as specified herein fit approximately 95% of the populationdue to the design and use of the air bladder/tourniquet technique. Thedesign is further unique in that this angle arc interface allows for asingular device to address such a large population of patients requiringno further adjustment in order to perform the surgical procedures ofmeniscectomy and/or ACL repair. Furthermore, it allows for theimplementation of a technique that does no require a tourniquet byapplying partial restrictive pressure to blood vessels via the airbladder, combined with cold saline, to perform meniscus repairs (the airbladder does not circumvent the patient limb/leg). The aspect that theair bladder does not circumvent the limb is also unique, as otherdevices with air bladders and/or foam padding circumvent the limb.

Opening 28 extends between the upper surface 24 and lower surface 27.The leg restraining member 20 provides sides 29, 30 that are preferablyflat and generally parallel. In FIGS. 3-10, restraining member 20 isprovided with an inflatable bladder 31.

The bladder 31 can be supplied with air through a valve 32. As indicatedby arrow 33 in FIG. 5, valve 32 can extend through opening 28.Inflatable bladder 31 can be attached to restraining member 20 usingadhesive 34 as indicated by arrow 35 in FIG. 5.

Inflatable bladder 31 can be attached to restraining member 20 using ahook and loop or Velcro® type connection, the hook fasteners 36 beingattached for example to inflatable bladder 31 while the loop fasteners37 are provided on the curved surface 27 of restraining member 20. Arrow38 in FIG. 7 illustrates an attachment of bladder 31 to restrainingmember 20 using a hook fastener 36 and loop fastener 37 connection.

In FIGS. 11-13, other arrangements of a restraining member are shown. InFIG. 11, restraining member 20A provides an ell shaped flanged member 40that is separate from curved section 21, the parts 21, 40 being joinedwith a connection 39 that is formed by a plurality of openings 41 inflanged member 40 that align with openings 43 through flanges 45, 46 ofcurved section 21. The parts 21 and 40 being secured with one or morebolted connections that can include a plurality of bolts 42 and nuts 44as shown in FIG. 11. Slot 47 provides a space in between the flanges 45,46 that is receptive of flange member 40.

In FIGS. 12 and 13, the restraining member 20B is first threaded througha leg cradle 48 having a projection 49 that cooperates with and connectsto a socket 50 provided on the restraining member 20B. In FIG. 13, theconnection has been complete, the vertical flange 22 of restrainingmember 20B extending through opening 73 of cradle 48 and then beingconnectable to the body 16 as with the embodiment of FIGS. 1-10.

FIGS. 14-18 show another embodiment of the apparatus of the presentinvention, designated generally by the numeral 51.

Leg restraining apparatus 51 provides a vertical flange 52 that isconnectable to the vertical slot 17 of body 16 using threaded set screw19 and internally threaded opening 18 as with the embodiment of FIGS.1-13. In FIG. 14, a cradle 53 has a flat underside that can be restedupon upper surface 12 of operating room table 11. Cradle 53 provides aconcavity 55 defined by curved surface 56 of cradle 53. Cradle 53provides a curved slot 57 that is receptive of belt 58. The belt 58 caninclude multiple belt sections 69, 70.

A belt free end portion 59 forms a connection with another belt free endportion 60. Outer surface 61 of each belt section 69, 70 can be providedwith transverse grooves 62 for increasing belt 58 flexibility. Each beltsection 69, 70 has an inner surface 63 that is generally smooth andcurved as shown. However, the inner surface 63 of each belt 58 or beltsection 69, 70 can also be provided with transverse grooves 64 as shown.

The belt free end portion 60 provides a handle 65 that enables a user totighten the free end portion 60 relative to the free end portion 59. Inthat regard, the free end portion 59 provides upwardly facing teeth 66,while the free end portion 60 provides downwardly facing teeth 67 asshown in FIGS. 14-18. If the belt 58 is formed of multiple belt sections69, 70, the curved slot 57 can provide teeth at 74 that form aconnection with the teeth 71, 72 of the belt sections 69, 70.

In FIGS. 15-16, the patient's leg 14 is shown secured within the beltsections 69, 70. A donut shaped pad 68 can be placed as an interfacebetween the belt sections 69, 70 and cradle 53 and the patient's leg 14.

FIGS. 19-21 show another embodiment of the apparatus of the presentinvention. In FIGS. 19-20, leg restraining apparatus 75 provides avertical flange 76 that is integrally attached to cradle 77. Cradle 77provides a flat surface or underside 78 that can rest upon the operatingroom table 11 upper surface 12. Cradle 77 provides a concavity 79defined by curved surface 80. The curved surface 80 can extend a full180 degrees as shown in FIG. 20 or can be less than 180 degrees as shownin FIG. 19. An ell shaped channel 81 extends through cradle 77 as shownin FIG. 19. Channel 81 extends to pinion gear 82 and then exits viaoutlet 96. The free end portion of belt 84 can be gripped at d-ring 89by a user as shown in FIG. 19, illustrated schematically by the arrow97. Belt 84 is a toothed belt, having a toothed surface 87 that engagesteeth 83 of pinion gear 82. Belt anchor pin 85 anchors belt 84 to cradle77 as shown in FIGS. 19 and 20. Belt anchor pin 85 is secured to pinopening 86, also extending through an opening at an end portion of thebelt 84.

Pinion gear 82 has a gear shaft 90 that is mounted to opposing sides ofcradle 77 as shown in FIG. 21. Locking pin 91 can be used to form aninterlocking connection with an opening 95 in gear plate 94 that isattached to and rotates with pinion gear 82. Locking pin 91 can providea knob 92 and spring 93. The spring 93 normally holds the locking pin 91in a locking position as is shown in FIG. 21. Knob 92 enables a user topull the pin away from pinion gear 82 for unlocking the pinion gear andenabling a user to tighten the belt 84. When a user releases the knob92, spring action provided by spring 93 thrusts the locking pin 91 backinto engagement with one of the openings 95 in plate 94 of gear 82.

The embodiment of FIGS. 19-21 can also be used with a donut shaped pad68, as is shown in FIGS. 15-16.

The following is a list of parts and materials suitable for use in thepresent invention.

PARTS LIST Part Number Description 10 leg restraint apparatus 11operating room table 12 upper surface 13 patient 14 leg 15 lockingmechanism 16 body 17 vertical slot 18 internally threaded opening 19threaded set screw 20 restraining member 20A restraining member 20Brestraining member 21 curved section 22 vertical flange/mounting flange22a inner surface 22b outer surface 23 thickened section 23a surface 23bsurface 23c surface 24 upper surface 25 longitudinal web 26 diagonal web27 lower surface 28 opening 29 side 30 side 31 inflatable bladder 32valve 33 arrow 34 adhesive 35 arrow 36 hook fastener 37 loop fastener 38arrow 39 connection 40 flanged member 41 opening 42 bolt 43 opening 44nut 45 flange 46 flange 47 slot 48 leg cradle 49 projection 50 socket 51leg restraining apparatus 52 vertical flange 53 cradle 54 flat underside55 concavity 56 curved surface 57 curved slot 58 belt 59 free endportion 60 free end portion 61 outer surface 62 transverse groove 63inner surface 64 transverse groove 65 handle 66 teeth 67 teeth 68 pad 69belt section 70 belt section 71 teeth 72 teeth 73 opening 74 teeth 75leg restraining apparatus 76 vertical flange 77 cradle 78 flat underside79 concavity 80 curved surface 81 ell shaped channel 82 pinion gear 83tooth 84 belt 85 belt anchor pin 86 pin opening 87 toothed surface 88smooth surface 89 d-ring 90 gear shaft 91 locking pin 92 knob 93 spring94 gear plate 95 opening 96 outlet 97 arrow

All measurements disclosed herein are at standard temperature andpressure, at sea level on Earth, unless indicated otherwise. Allmaterials used or intended to be used in a human being arebiocompatible, unless indicated otherwise.

The foregoing embodiments are presented by way of example only; thescope of the present invention is to be limited only by the followingclaims.

The invention claimed is:
 1. A leg restraining apparatus for use in kneesurgery on a leg of a patient, the leg having an upper portion and anunderside and a knee, and in combination with a surgical table uponwhich the patient is resting, comprising: a) a restraining memberremovably attached to the surgical table, the restraining member beingan integrally molded plastic member having a curved section with anupper convex surface and an underside concave surface that is positionedto engage the upper portion of the patient's leg from a position abovethe patient's leg but does not engage the underside of the patient'sleg; b) the restraining member adapted to prevent substantial movementof the patient's leg above the patient's knee while allowing movementand manipulation of a distal leg section below the patient's knee; c)the restraining member having first and second end portions, the firstend portion of the restraining member having a connector that enablesconnection to the surgical table, the second end portion of therestraining member being a free end portion opposite the connector; d)the restraining member having a thickened section that forms aninterface in between the connector and the curved section, the thickenedsection including first and second tapered sections that are joined at alocation of maximum cross sectional area of the thickened section; e)wherein said underside concave surface forms an arch in between theconnector and the free end portion; f) the thickened section including aplurality of surfaces including a first surface that is in directcommunication with the said underside concave surface, a second surfacethat is in communication with said upper convex surface and whichextends from the upper convex surface to the connector, and a thirdsurface that extends between said connector and said first surface; g)wherein said first and second surfaces form an acute angle; and h)wherein said first and third surfaces form an obtuse angle.
 2. A legrestraining apparatus constructed in accordance with claim 1 furthercomprising an inflatable cuff attached to said curved section.
 3. Theleg restraining apparatus of claim 2 wherein the inflatable cuff isconfigured to not encircle the patient's leg.
 4. A leg restrainingapparatus constructed in accordance with claim 2 wherein the inflatablecuff includes an aperture to facilitate inflation.
 5. A leg restrainingapparatus constructed in accordance with claim 1 further comprising acradle that is removably connectable to the restraining member, thecradle having an upwardly facing concavity that is adapted to cradle thepatient's leg from below.
 6. A leg restraining apparatus constructed inaccordance with claim 1 wherein the restraining member is of apolycarbonate material.
 7. A leg restraining apparatus constructed inaccordance with claim 1 wherein the restraining member is of a glasspolycarbonate blend.
 8. A leg restraining apparatus constructed inaccordance with claim 1 wherein the restraining member is of in excessof 50% long strand glass and polycarbonate plastic material.
 9. The legrestraining apparatus of claim 1 wherein the restraining member isadapted to extend half way around the patient's leg.
 10. The legrestraining apparatus of claim 1 wherein the first tapered section isattached to the connector and the second tapered section is attached tothe curved section, wherein the first tapered section has a smallestcross sectional area next to the connector.
 11. The leg restrainingapparatus of claim 1 wherein the first tapered section is attached tothe connector and the second tapered section is attached to the curvedsection, wherein the second tapered section has a smallest crosssectional area next to the curved section.
 12. The leg restrainingapparatus of claim 1 wherein the first tapered section has two surfacesthat form an acute angle.
 13. The leg restraining apparatus of claim 1wherein the second tapered section has two surfaces that form an acuteangle.
 14. The leg restraining apparatus of claim 1 wherein an obtuseangle is formed by one surface of the first tapered section and onesurface of the second tapered section.
 15. A leg restraining apparatusfor use in knee surgery on a leg of a patient, the leg having an upperportion and an underside and a knee and a distal leg section below theknee, and in combination with a surgical table upon which the patient isresting, comprising: a) a restraining member removably attached to thesurgical table, the restraining member being an integrally moldedplastic member having a curved section with first and second endportions, an upper convex surface, and an underside concave surface thatis positioned to engage the upper portion of the patient's leg from aposition above the patient's leg but does not engage the underside ofthe patient's leg; b) the restraining member adapted to preventsubstantial movement of the patient's leg while allowing movement andmanipulation of the patient's distal leg section below the patient'sknee; c) the restraining member having a connector that enablesconnection to the surgical table; d) the restraining member having athickened section that forms an interface between the connector and thefirst end portion of the curved section, the thickened section includingfirst and second tapered sections that are joined at a location ofmaximum cross sectional area of the thickened section; e) the thickenedsection including a plurality of surfaces including a first surface thatis in direct communication with said underside concave surface, a secondsurface that is in communication with the said upper convex surface atsaid first end portion of the curved section, and a third surface thatextends between said connector and said first surface, said first andthird surfaces forming an obtuse angle; f) wherein the curved sectionterminates at said second end portion opposite the connector; and g)wherein said underside concave surface forms an arch in between theconnector and the second end portion.
 16. A leg restraining apparatusconstructed in accordance with claim 15 further comprising an inflatablecuff attached to said curved section.
 17. The leg restraining apparatusof claim 16 wherein the inflatable cuff is configured to not encirclethe patient's leg.
 18. A leg restraining apparatus constructed inaccordance with claim 16 wherein the inflatable cuff includes anaperture to facilitate inflation.
 19. The leg restraining apparatus ofclaim 16 wherein the restraining member is adapted to extend half wayaround the patient's leg.
 20. A leg restraining apparatus constructed inaccordance with claim 15 wherein the restraining member is of apolycarbonate material.
 21. A leg restraining apparatus constructed inaccordance with claim 15 wherein the restraining member is of a glasspolycarbonate blend.
 22. A leg restraining apparatus constructed inaccordance with claim 15 wherein the restraining member is of in excessof 50% long strand glass and polycarbonate plastic material.
 23. The legrestraining apparatus of claim 15 wherein the first tapered section isattached to the connector and the second tapered section is attached tothe curved section, wherein the first tapered section has a smallestcross sectional area next to the connector.
 24. The leg restrainingapparatus of claim 15 wherein the first tapered section is attached tothe connector and the second tapered section is attached to the curvedsection, wherein the second tapered section has a smallest crosssectional area next to the curved section.
 25. The leg restrainingapparatus of claim 15 wherein the first tapered section has two surfacesthat form an acute angle.
 26. The leg restraining apparatus of claim 15wherein the second tapered section has two surfaces that form an acuteangle.
 27. The leg restraining apparatus of claim 15 wherein an obtuseangle is formed by one surface of the first tapered section and onesurface of the second tapered section.